Duns Number:793384496
Device Description: BONE AWL
Catalog Number
-
Brand Name
Quantum® Spinal Fixation System
Version/Model Number
10-AWL-10-30
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HWJ
Product Code Name
AWL
Public Device Record Key
5d344951-982a-4c75-8ffe-4ad2c1c856c4
Public Version Date
October 14, 2021
Public Version Number
3
DI Record Publish Date
September 30, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 3116 |
2 | A medical device with a moderate to high risk that requires special controls. | 5221 |